Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

NCT02541955 | Completed Phase 4 FDA Drug

• 1 other identifier: Acthar in Rheumatoid Arthritis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to determine in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or disease activity scores improve with Acthar treatment.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid arthritis (RA); Musculoskeletal ultrasound (MSUS)

Outcome Measures

Primary Outcomes (2)

• Ultrasound Power Doppler Score

  Using Ultrasound a measure of Power Doppler will be calculated. The change in the scores will be analyzed between the two groups.

  Baseline to 2 Weeks

• DAS28

  DAS28 will be calculated. The change in the scores will be analyzed between the two groups.

  Baseline to 2 Weeks

Secondary Outcomes (2)

• Ultrasound Grey Scale Synovial Hypertrophy score

  Baseline to 2 Weeks

• HAQ-DI

  Baseline to 4 Weeks

Study Arms (2)

40 Units

ACTIVE COMPARATOR

40 units of Acthar per week

Drug: Acthar

80 Units

ACTIVE COMPARATOR

80 units of Acthar twice per week

Drug: Acthar

Interventions

Acthar DRUG

Injections will be self administered

Also known as: Repository corticotropin injection

40 Units; 80 Units

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must meet 1987 ACR criteria
• Age \> 18 years of age
• Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) \>=3.2
• Stable concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs)
• Stable prednisone \<10mg or equivalent
• Power Doppler score of \>=10

You may not qualify if:

• Prior treatment with Acthar in the past 2mos
• Meet one of the above RA flare requirements
• Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine)

Sponsors & Collaborators

• Veena Ranganath, MD, MS: lead
• Mallinckrodt: collaborator

Study Sites (1)

UCLA David Geffen School of Medicine, Division of Rheumatology

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Veena K Ranganath, M.D., M.S.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 4, 2015
• Study Start: July 20, 2017
• Primary Completion: May 6, 2025
• Study Completion: May 20, 2025
• Last Updated: February 10, 2026

Record last verified: 2025-06

Locations

US (1)